Fri.Oct 25, 2024

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Q&A: Health Care Experts on H5 Bird Flu Vaccine Developments

Drug Topics

As the H5 bird flu outbreak gradually impacts human health in the US, health care experts weighed in on possibilities of a future vaccine.

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STAT+: For the behemoth UnitedHealth, a new threat to Medicare profits

STAT

For the nation’s largest health insurer, the evidence of abuse was stunning and unmistakable: UnitedHealth Group reaped billions from the federal Medicare program by diagnosing patients with serious chronic illnesses, and then delivering no follow-up care. The findings in the federal report reveal that UnitedHealth repeatedly sent clinicians into patients’ homes and pored over their medical charts to add diagnoses for illnesses such as vascular disease, heart failure, and diabetes.

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Denosumab Cost Effectiveness Varies in Postmenopausal Osteoporosis | AMCP Nexus 2024

Drug Topics

The cost effectiveness of biosimilar denosumab for postmenopausal osteoporosis varies significantly based on factors like adherence, subsequent therapies, and treatment duration.

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STAT+: Eli Lilly weight loss drug shortage underscores deeper issues with FDA oversight

STAT

A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans. Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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FDA Approves Sulopenem Etzadroxil and Probenecid for Uncomplicated Urinary Tract Infections

Drug Topics

“As the first oral penem approved in the US, Orlynvah offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market,” according to the CEO of Iterum Therapeutics.

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Ability to wed: When getting married could mean losing lifesaving medical benefits

STAT

When Chelsea Smith met Jason Martin she knew right away that he was the one — so she refused to get his phone number. That’s because getting married would make Smith ineligible for Social Security benefits and Medicaid — financial support that she and many others with disabilities need to survive. Smith didn’t want to risk falling in love knowing she couldn’t get married.

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More Trending

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In the era of GLP-1 drugs, demand for bariatric surgery plunges

STAT

For people with obesity, surgeries that shrink, reshape, or otherwise alter the anatomy of the stomach have long reigned supreme as the surest way to weight loss. But in the last few years, with the approval of GLP-1 drugs like Wegovy and Zepbound , more and more people are opting for obesity medicines over gold-standard surgical treatments.  “On a population level, among a subset of commercially insured individuals, that is the tradeoff that is happening” said Thomas Tsai, th

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FDA Approves Oral Sulopenem Etzadroxil and Probenecid for Uncomplicated Urinary Tract Infections

Pharmacy Times

Orlynvah is approved for uncomplicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

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Being a patient can be a full-time job. This ICU nurse wants to make it easier

STAT

Michael Anne Kyle had just begun her Ph.D. in health policy and management at Harvard Business School when her friends started complaining about the health care system. Many of them were having children for the first time, and they’d never been to the doctor so much in their lives. They’d text Kyle, who is also an ICU nurse, with gripes.

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GSK plans $800m US manufacturing investment

pharmaphorum

GSK has made another investment in its manufacturing network, setting aside $800 million to build two plants at its Marietta site in the US.The programme represents the largest capital spend by the UK drugmaker on production capacity to date and will double the size and capacity of GSK's existing medicines and vaccines facility in Marietta, Pennsylvania, creating around 200 new jobs.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Morning Rounds: Newborn screenings, radiation-proof tardigrades

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Fun fact: My Ph.D. dissertation was about destroying toxic “forever chemicals,” aka PFAS. This mostly means I am cursed with knowing too much about where these chemicals are used.

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Centene shares rise as it beats the Street on profit, revenue

Fierce Healthcare

Shares in Centene were up premarket Friday after the company beat Wall Street analysts' expectations on both profit and revenue for the third quarter. | Shares in Centene were up premarket Friday after the company beat Wall Street analysts' expectations on both profit and revenue for the third quarter.

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Opinion: Louisiana’s creative new ways to fight maternal mortality

STAT

You don’t have to be a public health professional to know that the U.S. has the  highest maternal mortality  rate of any high-income country. It’s chilling, sobering, and unacceptable. The situation is particularly dire for Black women, who are  four times more  likely to die than white women. Conditions are worse in Southern states.

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FDA Approves Estradiol Gel, 0.06% for Women Post-Menopause

Pharmacy Times

In postmenopausal women, the gel can reduce moderate to severe hot flashes as well as menopausal changes and symptoms.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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STAT+: Eli Lilly weight loss drug shortage underscores deeper issues with FDA oversight

STAT

A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans. Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years.

FDA 101
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Sanofi shrugs off potential RSV competition from Merck as Beyfortus grows sales 382%

Fierce Pharma

Despite Merck & Co. | Despite Merck & Co. homing in on approval for its infant respiratory syncytial virus antibody clesrovimab, Sanofi thinks Beyfortus can hold its own. On a Friday call with analysts, Sanofi execs pointed to an efficacy edge for its preventive and stressed that more competition in the space is a net positive.

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Intellia trumpets CRISPR drug data, but shares fall

pharmaphorum

Intellia reports a big reduction in hereditary angioedema attacks in patients treated with its one-shot CRISPR drug, but its share fall sharply

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BeiGene, ex-AstraZeneca exec faces investigation in China: reports

Fierce Pharma

A senior executive at BeiGene is under investigation by Chinese authorities, multiple local media outlets report. | A senior executive at BeiGene is under investigation by Chinese authorities, multiple local media outlets report. The company said it believes the investigation is not related to its activities.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Pharma companies must adapt to keep pace with AI developments, say experts

Pharmaceutical Technology

At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.

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After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah

Fierce Pharma

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. | Iterum's Orlynvah was approved by the FDA Friday to treat certain uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative antibacterial treatment options.

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STAT+: Pharmalittle: We’re reading about FDA oversight of shortages, AstraZeneca threats, and more

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to manicure the Pharmalot grounds, promenade with the official mascots, and sample some natural wonders. We also hope to hold another listening party, where the rotation will likely include this , this , this , this , and this.

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MSD buys Modifi for $1.3bn to boost oncology pipeline

pharmaphorum

MSD buys Modifi Bio in a $1.3bn deal, getting rights to a new class of drugs for difficult-to-treat cancers, including glioblastoma.

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100M people impacted by massive Change Healthcare cyberattack: OCR

Fierce Healthcare

UnitedHealth Group has officially disclosed that 100 million people were affected by the massive cyberattack on Change Healthcare earlier this year. | UnitedHealth Group has officially disclosed that 100 million people were affected by the massive cyberattack on Change Healthcare earlier this year.

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ICYMI: Total Pharmacy October 2024 Issue

Drug Topics

Don’t miss out on the latest pharmacy insights in the Total Pharmacy October issue.

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J&J, Eli Lilly pad immunology profiles with trial readouts in new patient groups

Fierce Pharma

Key drugs from Johnson & Johnson and Eli Lilly stand to bolster their respective cases in competitive dermatology markets with new data readouts. | Johnson & Johnson tested Tremfya in patients with plaque psoriasis involvement in "sensitive or highly visible areas," while Lilly weighed Ebglyss in atopic dermatitis patients who've previously tried Dupixent.

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FDA Grants Orphan Drug Designation to MDL-101 for Congenital Muscular Dystrophy Type 1a

Pharmacy Times

Congenital muscular dystrophy type 1a is a severe, early-onset condition that currently has no treatment, but MDL-101 may serve as a 1-time, durable treatment option.

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GSK pumps up to $800m for US manufacturing site upgrade

Pharmaceutical Technology

A new vaccines drug substance facility and R&D pilot plant, completed by the end of 2028, will create over 200 new jobs.

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Patients With Generalized Myasthenia Gravis Demonstrate Rapid Response Following Ravulizumab Treatment

Pharmacy Times

Utilizing data from the CHAMPION MG trial, investigators found that many patients had responded to ravulizumab and returned to daily activities within 2 weeks.

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Community Health Systems logs $391M loss in Q3, dragged down by payer denials, higher expenses

Fierce Healthcare

Community Health Systems, a 69-hospital system, posted $3.09 billion in third-quarter revenue, up slightly from a year ago, thanks to higher hospital patient volumes and growth in its ambulatory su | Community Health Systems, a 69-hospital system, posted $3.09 billion in third-quarter revenue, up slightly from a year ago and in line with Wall Street estimates.

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Understanding the Role of Oncology Pharmacists in Academic vs Community Cancer Centers

Pharmacy Times

Their expertise complements multidisciplinary teams in a variety of clinical settings.

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HCA bracing for $200M hurricane-related financial hit in Q4

Fierce Healthcare

HCA Healthcare took a $50 million financial hit in the third quarter due to the impacts of the back-to-back hurricanes Helene and Milton, which slammed facilities in North Carolina, Georgia and Flo | HCA Healthcare took a $50 million financial hit in the third quarter due to the impacts of the back-to-back hurricanes Helene and Milton, which slammed facilities in North Carolina, Georgia and Florida.

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Pharmacogenetics in Practice: Pharmacists’ Role in Navigating Clinical Challenges and Consensus Building in the Field

Pharmacy Times

Ryan Nelson, PharmD, discusses the STRIPE Annual Meeting and Consensus Workshop’s focus on unifying pharmacogenetic guidelines across major organizations, such as the FDA, European Medicines Agency, Clinical Pharmacogenetics Implementation Consortium, and National Comprehensive Cancer Network.

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NICE backs two AIs for remote heart failure monitoring

pharmaphorum

NICE backs two AI algorithms from Boston Scientific and Medtronic for monitoring heart failure patients, but turns down others from Biotronik and Abbott.

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